Vilazodone for Menopausal Hot Flashes

This is a proposal to conduct a small clinical trial for proof in principle that vilazodone
reduces the frequency and severity of menopausal hot flashes. An additional exploratory aim
is to identify improvement in menopause-related quality of life. Healthy, perimenopausal
women ages 45-60 with an average of 4 or more moderate or severe hot flashes/night sweats
per day for 3 screening weeks will be randomized to 8 weeks of treatment in a 2:1 ratio of
vilazodone or matching placebo pills. Flexible dosing of vilazodone will start at 10 mg
once/day for 7 days, increase to 20 mg/day for 1 more week and increase to 40 mg once/day at
week 3 if unimproved. The primary outcome assessments are the frequency and severity of hot
flashes at week 4 and week 8 as assessed by prospective daily diaries (using 7-day mean
scores from the daily diaries). The secondary outcome is clinical improvement, defined as
hot flash frequency >=50% decrease from baseline. Treatment-emergent adverse events will
be monitored and patient ratings of tolerability will be obtained.

Inclusion Criteria:

- Women ages 45-60 years

- Amenorrhea for 60 days or more or postmenopausal or bi-lateral oophorectomy.

- 4 or more moderate or severe hot flashes or night sweats per 24 hour period (28/week)
as recorded on daily diaries in 3 screening weeks.

- Hot flashes/night sweats rated as moderate to severe and/or bothersome (moderately to
a lot) on 4 or more days/nights in each screen week.

- In general good health.

- Signed informed consent.

Exclusion Criteria:

- Psychotropic medications currently or within the last 30 days.

- Current use of hormonal medications such as hormone therapy or hormonal contraception
or any treatment for hot flashes (Prescription, over-the-counter or herbal).

- Drug or alcohol abuse in the past year.

- Lifetime diagnosis of psychosis or bipolar disorder.

- Suicide attempt in the past 3 years or any current suicidal ideation.

- Current major depression.

- Not using a medically approved, non-hormonal method of birth control if sexually
active and not postmenopausal (12 or more months since last menstrual period or
bi-lateral oophorectomy).

- Pregnancy, intending pregnancy or breast feeding.

- Any severe of unstable medical illness, e.g., breast or ovarian cancer, seizure
disorders, etc.

- Current participation in another intervention study.

- Inability or unwillingness to complete study procedures.